August 15, 2019
Announcement no. 15
Q2 2019 Report
Highlights
Additional Information request from FDA on the pediatric application for The NGAL Test™ postpones clearance
In mid-July 2019, BioPorto received an additional information (AI) request from the U.S. Food & Drug Administration (FDA) on its May 2019 application for clearance of The NGAL Test™ for risk assessment of acute kidney injury (AKI) in children under the age of 22.
BioPorto has initiated a dialogue with the FDA to clarify the questions in the AI request and to support its application. Based on the progression of this dialogue, BioPorto may initiate analysis of additional retrospective clinical samples in cooperation with Cincinnati Children’s Hospital and other partner hospitals. The Company expects to submit a new application package to the FDA during the fourth quarter of 2019.
Enrollment of U.S. patients for The NGAL Test’s clinical study in adults continues as planned
In the second quarter of 2019 BioPorto continued enrollment of patients at three leading academic medical centers to supplement its clinical trial for The NGAL Test in adults.
The final application for risk assessment of The NGAL Test in adults is expected to be submitted to the FDA in Q4 2019.
U.S. organization expanded
To a prepare for a U.S. launch, build awareness of AKI and support increased study of NGAL, BioPorto has initiated commercial expansion in the U.S.
In the second quarter of 2019, BioPorto appointed Amy Winslow as President for its U.S. subsidiary, BioPorto Diagnostics, Inc. to lead the Company’s commercial organization. In addition, Dr. Christopher Bird has recently joined as BioPorto’s first Chief Medical Officer (CMO). Both Amy and Chris are members of BioPorto’s Corporate Management.
Successful share capital increase completed
In June 2019, BioPorto initiated a private placement cash issue of 9,256,577 new shares at nominally DKK 1 each, equivalent to 5.59% of BioPorto’s registered share capital prior to the capital increase. The subscription price was DKK 3.97 per share. The Board of Directors had received binding advance subscription commitments for the entire offering from existing shareholders and new investors, representing both domestic and international interests. The fully subscribed and successfully completed private placement was concluded in July 2019 and yielded gross proceeds of DKK 36.7 million.
Growth in second quarter 2019 revenue driven by solid performance in NGAL sales and antibodies
BioPorto’s revenue in the second quarter of 2019 grew by 10% to DKK 7.8 million compared to DKK 7.2 million last year. Two components drove growth: increased U.S. revenues from NGAL, up 43% in the quarter, and sales of antibodies which were positively affected by larger bulk orders.
BioPorto’s operating loss before interest and tax (EBIT) for the second quarter of 2019 was DKK 16.5 million, compared to a loss of DKK 10.0 million in the same period of 2018. Investment in the U.S. organization and the full-year effects of 2018 hiring were the main reasons for the change.
Revised sales and EBIT guidance for 2019
Based on the postponement of the anticipated FDA clearance of the pediatric indication for The NGAL Test, BioPorto has revised its expected revenue in the financial year 2019 from approximately DKK 40 million to approximately DKK 32 million. The revised revenue expectation corresponds to a growth rate of 23% over 2018.
The operating loss (EBIT) in the same period has been revised from a loss of approximately DKK 45 million to a loss of approximately DKK 65 million. The EBIT is primarily impacted by the reduced revenue, investment in the U.S. organization and extra costs for the pediatric clearance of NGAL due to the reported delay.
Peter M. Eriksen, CEO commented: “Following an intense second quarter where we strengthened our U.S. organization, completed a successful share issue, increased NGAL sales and submitted the U.S. pediatric application of The NGAL Test, we received questions from the FDA regarding our application in mid-July. The main questions were related to the test’s sensitivity. Together with a group of nephrologists and intensivists who are experts in the management of children with AKI, we have initiated a dialogue with the FDA to further describe the current clinical paradigm and the medical implications of our statistics, which we collectively believe represent an important advancement over the current standard of care. While the clearance and commercialization of NGAL has been delayed from our initial expectation, I remain very confident that we will succeed in introducing a new tool to advance the early detection of AKI risk.”
Extraordinary General Meeting and Investor meeting
The Board of Directors of BioPorto will convene an extraordinary general meeting (EGM) in order to elect two new members to its Board. Proposed are: Christopher Lindop, a U.S. citizen with considerable experience in management of U.S. listed healthcare companies, including expertise in finance and reporting, corporate governance, mergers & acquisitions, funding, and strategy development; and Michael Singer, a U.S. citizen who is an entrepreneurial M.D./Ph.D. with significant experience in designing and executing pre-clinical and clinical development processes and successfully building biotech and healthcare companies.
The EGM will be held on August 15, 2019 at 2:00 PM (CET) at BioPorto’s address Tuborg Havnevej 15 st., 2900 Hellerup, Denmark.
Following the EGM and at the same venue, BioPorto will, in connection with the release of the interim report for first half of 2019, host an investor meeting at 3:00 PM (CET). To attend the investor meeting, please sign up at investor@bioporto.com.
For further information, please contact:
Ole Larsen, CFO
Telephone +45 4529 0000, e-mail investor@bioporto.com
About BioPorto
BioPorto is an in vitro diagnostics company that provides tests and antibodies to clinicians and researchers around the world. We use our antibody and assay expertise to transform novel research tools into clinically actionable biomarkers that can make a difference in patients’ lives. BioPorto is headquartered in Hellerup, Denmark and is listed on the NASDAQ Copenhagen stock exchange [CPH:BIOPOR].
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